Senator’s Descent Into Anti-Science; Secret ‘Project Onyx’; Bad Texas Psych Care

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Senator’s Descent Into Anti-Science

Sen. Ron Johnson (R-Wisc.) has a history of publicly disputing and playing down science, even when — as some sources say — he doesn’t believe in what he’s saying, the Milwaukee Journal Sentinel reported.

Johnson, who recently has come under fire for challenging COVID vaccines, also questioned the effectiveness of mask-wearing during the pandemic, downplayed COVID-19’s severity as a disease, and supported the discredited hydroxychloroquine as a COVID treatment.

“When the pandemic hit, Johnson, then the chair of the Homeland Security and Governmental Affairs committee, held three hearings on the crisis, and the Senator and his hand-picked witnesses made claims unsupported by solid evidence,” according to the article.

Johnson has previously spoken out against the science supporting climate change and opposed FDA regulations countering the e-cigarette industry.

“For decades, various industries have waged propaganda efforts to undermine scientific findings that threatened their profits,” the newspaper noted. “Now, some politicians are increasingly willing to ignore or discount mounting scientific research for political gain.”

Johnson tested positive for COVID in October. He later said he was never symptomatic after taking zinc, and vitamins C and D. He would have taken hydroxychloroquine if he developed symptoms, he said.

Johnson joined the Senate during the emergence of the Tea Party in 2010. A former Republican Congressman from Florida said Johnson has “since gone through a ‘fascinating evolution’ from when he was first recruited to run for the Senate as a ‘Chamber of Commerce, sensible conservative.’ Now, he said, Johnson is embracing an anti-science wing of the Republican Party.”

Johnson declined to be interviewed for the story, but issued written responses. He noted that it’s merely an opinion to call his scientific positions extreme and that scientific consensus ‘has been proved wrong many times before.’

Alzheimer’s Drug & Cozy FDA Connections

Biogen had discussed the possibility of accelerated approval of aducanumab (Aduhelm) with the FDA long before internal agency documents suggest, an investigation by STAT News found.

The article tells the history of the compound — from its inception at a meeting of scientists in the Swiss Alps in 2005 to the agency green-lighting it earlier this month — and how the company made a powerful alliance with a top FDA official that likely contributed to its success.

The trouble started with a fateful interim analysis that was supposed to bolster investor confidence but ultimately turned up negative and nearly sunk the company. Not long after it was announced, a re-analysis of the data followed, and company R&D executive Al Sandrock, MD, PhD, had a quiet meeting with Billy Dunn, MD, director of the FDA’s office of neuroscience — who ended up becoming an ally of sorts.

After that meeting, Biogen launched “Project Onyx” (the code name “Project Phoenix” was rejected by company lawyers), according to STAT.

At a meeting between the FDA and Biogen on June 14, 2019, the possibility of accelerated approval of aducanumab was discussed, the outlet reported, even though recently released internal FDA documents said that idea wasn’t raised until March 31 of this year.

During that meeting, Dunn’s group offered five scenarios for its aducanumab review — and only one involved conducting an additional trial. According to portions of an agency memo read to a STAT reporter, the FDA told Biogen that aducanumab might be granted accelerated approval based solely on its ability to remove amyloid plaques from the brain.

The FDA never mentioned the discussions about accelerated approval to its November advisory committee, STAT reported.

“This is surprising and, if true, concerning because I do think the advisory committee has the right to understand what FDA is considering,” Susan Wood, PhD, of George Washington University and former assistant commissioner at the FDA, told STAT. “The whole point of advisory committees is to discuss the range of data and questions that remain about the data. If they were thinking of that pathway it should have been brought to the advisory committee.”

Dunn was criticized following that meeting for what STAT described as a “jarring display of advocacy.”

Ultimately the decision about accelerated approval rested with Patricia Cavazzoni, MD, the head of the agency’s Center for Drug Evaluation and Research.

“Biogen is likely to book billions of dollars in sales from this new drug,” the article states. “Once again, the company has managed to pull out a transformative win. Once again, it can thank Al Sandrock. This time, though, the public at large is left to wonder if the victory had to do with more than amazing science.”

Texas-Sized Gap in Psychiatric Hospital Oversight

While Texas has closed just one psychiatric hospital since 2014, a Houston Chronicle investigation revealed centers with more serious violations — which remain open.

Sacred Oak Medical Center, just outside Houston, was shuttered by the state in 2014 after being cited with 74 combined state and federal violations in its 3 years of existence. Cedar Crest Hospital in Belton has been charged with more violations, and it remains open.

Like Sacred Oak, 33 other Texas hospitals were cited for having hazardous materials and ligature risks, and 33 others were chastised for not updating treatment plans.

At the same time, the state lacks enough hospital beds to keep up with increases in its psychiatric patient population.

The state’s 10 public psychiatric hospitals had a waitlist of nearly 1,500 people as of March, and people waited an average of 180 days for a non-maximum security bed and 366 days for a maximum security bed.

While advocates say states need 50 public beds per 100,000 people, Texas has fewer than 8 beds per 100,000.

The Chronicle analyzed more than 1,200 files pertaining to 70 private facilities.